BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    MDR report key: 2220030 · Received August 9, 2011

    Report

    Report Number
    2024601-2011-00623
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    March 8, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2011. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED AS THE DEVICE WAS NOT EXPLANTED. BASED UPON THE IMPLANT DATE PROVIDED BY THE RPTR THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. NO ADD'L INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    PT REPORTED AN ALLEGED LEAK IN THE TUBING CLOSE TO THE PORT. THE PT STATED THAT THERE WAS NO FEELING OF RESTRICTION FROM THE BAND, SO THE PT VISITED THE DOCTOR WHO PERFORMED A FILL. THE PT HAD TWO ADD'L OVER A SPAN OF THREE WEEKS AND EACH TIME WOULD RETURN WITH NO FLUID IN THE BAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE) LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR